ISO-19011-Discussion-Groups.doc

ISO 19011 Discussion GroupsSummary of articles covering the developing standard. The source of this information is the web and the sources and copyrights are acknowledged.TO: US TAGs to TC176 & TC207, US National Standards Public Commentors, Other Interested PartiesFROM: US Delegates to ISO Joint Working Group Developing ISO 19011 and Chairs, US TAG Work Groups John Stratton and Bart Solomon;TC176 Bud Smith, Gary Johnson, and Tom Ott; TC207SUBJECT: Request for Ballot on ISO/DIS 19011ISO 19011 CD3 was revised earlier this year and published as a Draft International Standard (DIS) in late May. Several improvements were made, but one significant issue remains, which we strongly believe will cause confusion with auditor qualification and competence and contribute to continued lack of use for this standard in the marketplace. The US Liaison Group between our TAGs to TC176 and TC207 has developed a detailed “position paper” describing the background and rationale for a proposed US ballot. ISO 19011CD3今年早些时候已经修订完成，并在五月后作为DIS发布。作了一系列的改进，但在一个意义重大的发布中仍留有，我们强烈的相信，对于审核员的资格和能力会引起混淆和对这个标准的应用的持续的缺乏。在TAG和TC176之间的美国联系组已经发布了一个详细的定位论文，描述美国人投票的背景和原理。Please review the attached “position paper” along with the DIS text published on the US Standards Group website, , or accompanying this request, and, if you agree with the position, vote to “disapprove with comment” on the ballot. The wording of a general comment will be prepared by the delegation and submitted with our official US response. Any suggested wording and additional comments should be prepared using the template provided. It is again important to strictly adhere to the template conventions to allow compilation of the comments by electronic means. Please submit your completed template to Erin Hogg, ASQ Standards Coordinator, at no later than August 31, 2001. 评价附加的定位论文可以访问下列网站。 或如果你同意该定位，We expect another meeting of the JWG on Auditing to be held late this year during which we hope to rectify this important issue with the DIS, and possibly, publish a second DIS. Thank you, in advance, for your comments and ballot, and thank you for yourcontinuing interest in this important standard for auditing quality andenvironmental management systems.The US Delegates to JWG on Auditing and US TAG Work Group ChairsU.S. Position Paper (15 June 2001) - U.S. Recommended Action Auditor Competence Issues in ISO/DIS 19011 It is recommended that the U.S. Technical Advisory Groups (TAGs) to ISO Technical Committees 176 and 207 submit a vote to “disapprove with comments” for ISO /DIS 19011. The principal reason for this vote is to support the removal of references to recommended or suggested levels of auditor experience for any specific auditing situation. Inclusion of such recommended levels of experience is inconsistent with the stated goals of the standard and may create considerable confusion among users. Examples may be permitted, but should include internal and supplier audit examples in addition to third-party certification audits in order to cover the full range of audit activities. Background ISO is in the latter stages of developing a new standard providing guidelines for auditing both quality and environmental management systems. This auditing standard, ISO 19011, is intended to fulfill the needs identified for audits under the ISO 9000 and ISO 14000 series of international management systems standards. ISO 19011 is being drafted by a Joint Work Group (JWG) formed from members of ISO Technical Committee 176 on Quality Management and ISO Technical Committee 207 on Environmental Management. Although the standard has reached the Draft International Standard (DIS) stage, several important issues remain to be resolved in the area of auditor competence. The goal of ISO 19011 is to provide clear, general guidance for principles of auditing, managing an audit program, conducting audit activities, and determining the competence of auditors for the full range of auditing activities encompassing first, second, and third party audits. While most of the draft standard appears to have fulfilled that goal, Clause 7, Competence of Auditors, remains an awkward mix of general guidance and specific criteria for auditors carrying out particular audit assignments. That section of the ISO/DIS 19011 includes specific “recommended” expectations for auditor experience for third party auditors. Similar “recommendations” are not provided for internal and second party auditors. Such suggestions may be confusing to many potential users of the standard and may be better addressed by other groups having direct responsibilities for audit certification. The Issue: Process versus Recommended Values - Possible Options ISO is the internationally accepted developer of the standards for quality and environmental management systems and for the processes involved in auditing them, but ISO itself does not accredit or operate audit programs. In the early planning stages of the ISO 19011 standard, the JWG identified several groups as having natural roles and interests in auditor competence. The International Accreditation Forum (IAF) is a group of accreditation bodies, representing different countries, with interest in the “third-party” certification process for quality and environmental management systems based on the ISO 9001 and 14001 standards. These certifications depend largely on auditors who conform to ISO auditing standards. In addition, the International Auditor and Training Certification Association (IATCA) is a group of auditor training and certification bodies with interests in assuring auditor competence. Both the IAF and IATCA can bring particular strengths and emphasis to the auditor competence issue. The current ISO auditing standards for quality management (i.e., ISO 10011 Parts 1, 2, and 3) and for environmental management (i.e., ISO 14010, 14011, and 14012), provide guidance for the audit process and for specific auditor competence criteria recognized as appropriate for “third-party” applications. As the implementation of quality and environmental management systems increased, other applications of audit processes increased as well to include first party or internal audits and second party or supplier audits. It became clear that any new auditing guidance needed to address the full range of auditing activities that users would encounter. This recognition was included in the scope of ISO 19011 from its inception. In the current auditing standards, the competence criteria listed were not appropriate for all auditors, especially the “internal auditors” who may audit less frequently and/or may audit only a portion of a system. The current standards would appear to require such internal auditors to have a measure of “competence” equivalent to that for third party certification auditors. This concept has been carried over to ISO 19011 and creates a significant issue that needs resolution. While the DIS lists the auditor competence criteria as “illustrations” of work experience that are “recommended “ for certification audits, valid questions have been raised as to whether ISO should recommend such criteria or whether it should remain focused on auditing processes. Much of Clause 7 deals with general processes for initially evaluating auditors and for assuring their ongoing competence. It is questionable whether ISO should, in 19011, go further to assume the role of organizations and international and national accrediting bodies by setting recommended work experience numeric guidelines. Audit programs, even for third-party certification, may vary among user countries and their needs. Certainly, auditor competence criteria for internal and supplier audits will be set ultimately by individual organizations to meet the particular needs of their management systems. Similarly, the specific criteria levels proposed in ISO/DIS 19011 might not be applicable in all countries with some opting for higher or lower levels. These specific decisions should be left to the organization in the case of internal audit programs or the “Conformity Assessment Process” and auditor certification bodies in the case of external, third-party certification/registration audit programs. Several options are available: ISO can continue to provide the guidance for auditing management systems and provide a standard for specific auditor competence criteria, ISO can continue to provide the guidance for auditing management systems and leave specific auditor competence criteria to others, or ISO can partner with IAF, IATCA, and any other interested parties, to establish the acceptable criteria for certification of auditor competence. The U.S. believes that, as a minimum, the standard should contain guidance for auditing management systems and leave the setting of specific auditor competence criteria to appropriate users of the standard. Those users may be individual companies or organizations, national certification or accreditation bodies, or organizations like IAF and IATCA. The ISO process for the review and revision of a standard requires several years and normally occurs only on a five-year cycle. It is reasonable to question whether or not ISO can respond to changing needs in the auditing community quickly enough to be effective. On the other hand, the IAF, IATCA, and national certification or accreditation processes are capable of much quicker response to the needs of the auditor community for training and certification. The JWG initially planned to provide only general guidance in the new ISO 19011 auditing standard and to let the IAF set auditor competence criteria for certification/registration auditors in cooperation with IATCA which plays a key role in helping to assure auditor competence. Rationale for Recommended Actions The U.S. believes that ISO 19011 should provide the general guidance for establishing and implementing audit programs and audit activities for all management system audits and provide the guidance for establishing and evaluating auditor competence. In this way, the overall goal of ISO 19011 to provide guidance on the full range of audit activities can best be achieved. The specific levels or work and audit experience are best left to be defined by the individual companies or organizations, national certification or accreditation organizations, IAF, and IATCA. The text in Clause 7 should be revised to remove references to recommended or suggested levels of auditor experience for any specific auditing situation. If examples are included, they should address internal and supplier audit examples in addition to third-party certification audits and be incorporated in one or more annexes to the Standard. Unfortunately, ISO rules require a negative vote during balloting on a DIS in order for a substantive revision to be made. The JWG leadership acknowledged in the closing plenary session in Sydney that substantive comments would be accepted, but the requirement for a negative vote was not mentioned. ISO DIS 19011 has generally appropriate guidance in all areas except the auditor evaluation section of Clause 7 on competence of auditors. While the U.S. recognizes the adequacy of most of the text in ISO DIS 19011, the U.S. is prepared to vote “no” on the DIS ballot in order to assure that original stated purpose of the standard is satisfied by an appropriate revision to Clause 7. We urge the U.S. stakeholders reviewing this Draft International Standard to cast their vote as “disapprove with comments” on the DIS ballot on the Standard in order to support this clearly necessary improvement. The New ISO 19011- Auditing Guidelines for IS0 9001:2000 By Jim Robison, 3rd Party Registrar Lead Auditor ISO 19011. Have you heard about it yet? If not, you will soon. This is latest ISO auditing guideline that will be released in mid 2001. It is now in a Committee Draft (CD) stage and work continues to make this the core Auditor guideline for ISO 9001:2000 Quality Management Systems (QMS) and ISO 14001 Environmental Management System (EMS) auditing. ISO 19011 will replace the current auditing guideline called ISO 10011.New Terms ISO 19011 has several new terms that both Internal and Lead Auditors need to learn. For example, the term Audit Criteria has been introduced. Audit criteria are now defined as The set of policies, procedures or other requirements against which collected evidence is compared. Also, the term Audit Findings is redefined under ISO 19011 as The results of the evaluation of the collected audit evidence against audit criteria. Many of us used to call a Finding a type of Noncompliance, but not any more under 19011. Terms such as Concerns, Observations, and Opportunities for Improvements, as well as Positive Observations and Noncompliances may now be defined as Audit Findings. ISO 19011 defines Audit Conclusions as The outcome of an audit reached by the audit team after consideration of all the audit findings. Confusing? Not really, you will just have to learn the new terms. Terms and definitions need to be understood and used consistently by auditors under the new ISO 9001:2000 and ISO 140001 standards. Principles of ISO 19011 ISO 19011 is focused on reemphasizing solid auditing principles. These are the most prominent: 1.Independence: Auditors cannot audit work where a conflict of interest would arise. 2.Ethical Conduct: Actions that may influence the results of an audit should be avoided. 3.Fair Presentation: Obligation to truthfully & accurately report QMS inadequacies. 4.Evidence: The rational basis for reaching audit conclusions based on audit criteria. 5.Due Audit Care: The reasonable care in all matters and the completeness of the audit report. Auditors should avoid errors that may comprise any of the above-mentioned principles. Auditing under ISO 19011 Under these ISO 19011 principles, the audit output should result in an audit containing these distinctive characteristics: *Objective, systematic and independent audits which produce information from management to improve operations. *Authorized, planned and properly managed audits that have a clear purpose and used defined techniques. *Relevant, reliable, sufficient and consistence audit evidence and audit conclusions that are reproducible. *Competent auditors free from biases and any conflict of interest. *A relationship between all parties involved in the audit that ensures confidentiality of the results. *Appropriate audit sampling to obtain the required evidence of conformance. It is the responsibility of the auditor, client and auditee to control these stated features of an audit activity, which